Estradiol

Sold as Femigel, Climara, Estring, Evorel, Novofem, Mesalin, Estrofem

S4Read from the PI-PIL document and verified

C₁₈H₂₄O₂272.40 g/mol

(8R,9S,13S,14S,17S)-13-Methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol

Drag to rotate. Structure from PubChem CID 5757.

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Registration

Applicants: 6
Registrations: 10
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Medi Challenge (Pty) Ltd	Femigel	1,5 mg	280600	S4	PI PIL
Bayer (Pty) Ltd û IsandoCancelled	Climara	100	290611	Not determined	None
Pfizer Laboratories (Pty) LtdCancelled	Estring	Not stated	290720	Not determined	None
Adcock ingram limited	Evorel	1,6 mg/ 3,2 mg/ 4,8 mg/ 6,4 mg	300207, 300208, 300209, Z0339	S4	PI PIL
Novo Nordisk (Pty) Ltd û (Rivonia)Certificate held by Novo Nordisk (Pty) Ltd., Novo Nordisk (Pty) Ltd	Novofem, Estrofem	1 mg, 1 mg & 2 mg	370297, J0214	S4	PI PIL
Intervet South Africa (Pty) LtdCancelled	Mesalin	Not stated	98/3	Not determined	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Femigel EACH 2,5 g GEL CONTAINS ESTRADIOL 1,5 mg	1,5 mgTransdermal gel	28060028/21.8.1/0600Approved 17 February 2026	Registered	S4	PI PIL
Climara 100 EACH 25 cm PATCH CONTAINS : ESTRADIOL 7,8 mg	100	29061129/21.8.1/0611	Cancelled	Not determined	None
Estring EACH VAGINAL RING CONTAINS ESTRADIOL (HEMIHYDRATE) 2 mg	Not listed	29072029/21.8.1/0720	Cancelled	Not determined	None
Evorel 25 EACH PATCH CONTAINS ESTRADIOL 1,6 mg	1,6 mg/ 3,2 mg/ 4,8 mg/ 6,4 mgTransdermal patch.	30020730/21.8.1/0207Approved 17 December 2021	Registered	S4	PI PIL
Evorel 75 EACH PATCH CONTAINS ESTRADIOL 4,8 mg	1,6 mg/ 3,2 mg/ 4,8 mg/ 6,4 mgTransdermal patch.	30020830/21.8.1/0208Approved 17 December 2021	Registered	S4	PI PIL
Evorel 100 EACH PATCH CONTAINS ESTRADIOL 6,4 mg	1,6 mg/ 3,2 mg/ 4,8 mg/ 6,4 mgTransdermal patch.	30020930/21.8.1/0209Approved 17 December 2021	Registered	S4	PI PIL
Novofem EACH TABLET CONTAINS NORETHISTERONE ACETATE A OESTRADIOL HEMIHYDRATE A	1 mg.Film-coated tablet.	37029737/21.8.2/0297Approved 26 August 2025	Registered	S4	PI PIL
Mesalin EACH 1,0 ml SOLUTION CONTAINS ESTRADIOL BENZOATE 0,2 mg	Not listed	98/398/22.6.1/3	Cancelled	Not determined	None
Estrofem EACH TABLET CONTAINS ESTRADIOL 2 mg	1 mg & 2 mgFilm-coated tablets.	J0214J/21.8.1/214Approved 17 February 2025	Registered	S4	PI PIL
Evorel 50 EACH PATCH CONTAINS ESTRADIOL 3,2 mg	1,6 mg/ 3,2 mg/ 4,8 mg/ 6,4 mgTransdermal patch.	Z0339Z/21.8.1/339Approved 17 December 2021	Registered	S4	PI PIL

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S4, read from the product's PI-PIL leaflet.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Estradiol

S4: Estradiol
- when intended for hormone replacement therapy;
- except when intended for human vaginal use; (S2)
- except when intended for oral contraception. (S3)
Consolidated Schedules 06 July 2026, lines 6246 to 6251
S3: Estradiol
- when intended for oral contraception;
- except when intended for human vaginal use; (S2)
- except when intended for hormone replacement therapy. (S4)
Consolidated Schedules 06 July 2026, lines 3514 to 3524
S2: Estradiol
- when intended for human vaginal use;
- except when intended for oral contraception; (S3)
- except when intended for hormone replacement therapy. (S4)
Consolidated Schedules 06 July 2026, lines 1927 to 1933

Pharmacological class: Oestrogens. (class 21.8.1)

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Femigel, Medi Challenge (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsFemigel, Medi Challenge (Pty) Ltd Patient information leaflet (PIL)For patients and carersFemigel, Medi Challenge (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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